Objective: To compare the effect of Prednisolone and placebo on the recovery of unilateral idiopathic sudden sensorineural hearing loss.
Study design: Prospective, randomized, triple-blind, placebo-controlled multicenter trial.
Setting: Four tertiary and 10 secondary referral centers.
Patients: Of 103 patients randomly assigned, 93 were included in the modified intention-to-treat analysis. The patients, aged 18 to 80 years, were seeking care within 1 week after onset of acute unilateral sensorineural hearing loss with a mean decrease of 30 dB or greater in the 3 most affected contiguous frequencies.
Intervention: Patients were randomly assigned in permuted blocks of 10 to receive Prednisolone or placebo in tapering doses from 60 mg for 3 days and, thereafter, 10 mg less each day until Day 8. If complete recovery, no more medication given, otherwise medication continued at 10 mg per day until Day 30. Final follow-up was after 3 months with audiogram; 47 patients received Prednisolone and 46 placebo.
Main outcome measure: The primary endpoint was efficacy of treatment on recovery at Day 90. Secondary endpoints were prognostic factors for hearing recovery. Analyses were by modified intention-to-treat and per protocol.
Results: Hearing improvement for 47 Prednisolone-treated patients was 25.5 ± 27.1 dB compared to 26.4 ± 26.2 dB for 46 placebo-treated patients at Day 8 and 39 ± 20.1 dB versus 35.1 ± 38.3 dB after 3 months. Vertigo had significant negative effect on hearing improvement and inflammatory signs in the laboratory workup-a positive prognostic effect, irrespective of treatment.
Conclusion: Prednisolone in customary dosage does not seem to influence recovery of idiopathic sudden sensorineural hearing loss.